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GDF 15 in Sickle Cell Disease and Hereditary Spherocytosis

Sponsor
Wolfson Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT01201135
Collaborator
(none)
80
Enrollment
12
Duration (Months)

Study Details

Study Description

Brief Summary

Patients with thalassemia intermedia, congenital dyserythropoietic anemia type I , and sideroblastic anemia were found to express very high levels of serum GDF15, and this contributed to the inappropriate suppression of hepcidin with subsequent secondary iron overload.The aim of our present study is to asses the levels of GDF15 and hepcidin in patients with Sickle cell disease and hereditary spherocytosis

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The identification of the ferroportin/hepcidin axis has allowed the effect of erythroid activity on iron balance to be studied and has created the basis for better defining the erythroid regulators.

    In iron-loading anemias, ineffective erythropoiesis suppresses hepcidin production, which result in dysregulating iron homeostasis. Miller and co-workers showed that release of cytokines like growth differentiation factor 15 (GDF15) during the process of ineffective erythropoiesis inhibits hepcidin production, thus defining a molecular link between ineffective erythropoiesis, suppression of hepcidin production and parenchymal iron loading.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    80 participants
    Time Perspective:
    Prospective
    Official Title:
    The Impact of Growth Differentiating Factor (GDF) 15 in Sickle Cell Disease and Hereditary Spherocytosis
    Study Start Date :
    Sep 1, 2010
    Anticipated Primary Completion Date :
    Sep 1, 2011
    Anticipated Study Completion Date :
    Sep 1, 2011

    Arms and Interventions

    Arm Intervention/Treatment
    Sickle cell disease
    hereditary spherocytosis.

    Outcome Measures

    Primary Outcome Measures

    1. GDF 15 [year]

    Secondary Outcome Measures

    1. Hepcidine [year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    5 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • non
    Exclusion Criteria:
    • non

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Wolfson Medical Center

    Investigators

    • Principal Investigator: GHOTI HOSSAM, doctor, HEMATOLOGY DEPARTMENT ON WOLFSSON MEDICAL CENTER

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01201135
    Other Study ID Numbers:
    • GDF-15CTIL
    First Posted:
    Sep 14, 2010
    Last Update Posted:
    Sep 14, 2010
    Last Verified:
    Sep 1, 2010
    Additional relevant MeSH terms:
    Anemia, Sickle Cell
    Thalassemia
    beta-Thalassemia
    Spherocytosis, Hereditary
    Anemia, Dyserythropoietic, Congenital

    Study Results

    No Results Posted as of Sep 14, 2010